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# GSK NDA Accepted for New Antibiotic
- URL: https://www.fdaweb.com/gsk-nda-accepted-for-new-antibiotic/
- Published: 2024-10-16T12:00:00.000Z
- Updated: 2026-09-14T14:44:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157993

FDA has accepted for priority review a GSK NDA for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for treating female adults and adolescents with uncomplicated urinary tract infections (uUTIs). The company says new treatments are needed as uUTIs caused by drug-resistant bacteria are increasing, which can lead to higher treatment failure rates. The agency has set a user fee review action target date of 3/26/2025.

GSK says gepotidacin works by inhibiting bacterial DNA replication by a distinct binding site that “provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as *E. coli* and *S. saprophyticus*), and *N. gonorrhoeae*, including isolates resistant to current antibiotics.”

The submission is based on data from the pivotal Phase 3 EAGLE-2 and EAGLE-3 trials. In the studies, GSK says gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI. In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin — 58.5% of participants treated with gepotidacin had therapeutic success compared to 43.6% for those treated with nitrofurantoin. In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% of participants compared to 47.0% for those taking nitrofurantoin.

GSK says gepotidacin’s safety and tolerability profile was consistent with previous trials of the antibiotic. The most common reported adverse events were diarrhea (16% of participants) and nausea (9%).